UMIN-CTR Clinical Trial

Basic information
Public title	Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Acronym	The study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Scientific Title	Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Scientific Title:Acronym	The study to evaluate the effect of nicotinamide mononucleotide (NMN) on the body composition in elderly persons
Region	Japan

Condition
Condition	healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of NMN oral administration on the body composition in elderly persons
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the skeletal muscle index by the bioelectrical impedance analysis
Key secondary outcomes	1) To evaluate the parameters related to glucose metabolism 2)To evaluate the vascular endothelial function by FMD

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects receive 250 mg/day of NMN for 12 weeks.
Interventions/Control_2	Subjects receive placebo for 12 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	65 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1)the healthy subjects who agree to the study. 2)Body Mass Index 22-28 3)no smoking history
Key exclusion criteria	1)The subjects who take functional food that may affect the trial 2)The subjects who take more than one hour daily exercise for more than 6 months 3)The subjects with the history of serious disease (malignant neoplasms, cardiac failure and myocardial infarction ) 4)The subjects with chronic disease 5)The subjects who take medicines 6)The subjects with allergic disorders. 7)The subjects who participate in any clinical trial within 90 days of the commencement of the trial 8)The subjects judged as ineligible by clinical investigators
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Igarashi
Organization	The Unversity of Tokyo Hospital
Division name	Department of Diabetes and Metabolic Diseases
Zip code	113-8655
Address	7-3-1 Hongo Bunkyo-ku
TEL	03-3815-5411
Email	igarashi-tky@umin.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Igarashi
Organization	The University of Tokyo Hospital
Division name	Department of Diabetes and Metabolic Diseases
Zip code	113-8655
Address	7-3-1 Hongo Bunkyo-ku
TEL	03-3815-5411
Homepage URL
Email	igarashi-tky@umin.ac.jp

Sponsor
Institute	Department of Diabetes and Metabolic Diseases, The University of Tokyo Hospital
Institute
Department

Funding Source
Organization	Mitsubishi Corporation Life Sciences Limited
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The University of Tokyo, Clinical Research Review Board
Address	7-3-1 Hongo Bunkyo-ku
Tel	03-5841-0818
Email	ethics@m.u-tokyo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 02 Month 07 Day
Date of IRB	2019 Year 03 Month 29 Day
Anticipated trial start date	2019 Year 06 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 03 Month 27 Day
Last modified on	2021 Year 03 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040733